Efficacy and Safety of Dexlansoprazole MR Compared to Placebo on Maintaining Healing in Subjects With Healed Erosive Esophagitis
NCT ID: NCT00321737
Last Updated: 2012-02-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
445 participants
INTERVENTIONAL
2006-05-31
2007-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Dexlansoprazole MR 30 mg QD
Dexlansoprazole MR
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to six months.
Dexlansoprazole MR 60 mg QD
Dexlansoprazole MR
Dexlansoprazole MR 60 mg, orally, once daily for up to six months.
Placebo
Placebo
Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.
Interventions
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Dexlansoprazole MR
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to six months.
Dexlansoprazole MR
Dexlansoprazole MR 60 mg, orally, once daily for up to six months.
Placebo
Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Use of antacids (except for study supplied) throughout the study.
* Use of drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose throughout the study.
* Chronic (\>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors.
* Need for continuous anticoagulant therapy.
* Evidence of uncontrolled systemic disease.
* Subjects who have participated in either maintenance study (T-EE04-086 \[NCT00255164\] or T-EE04-087 \[NCT00255151\]).
* Subjects who, in the opinion of the investigator, is unable to comply with the requirements of the study or is unsuitable for any reason.
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_CHAIR
Takeda
Locations
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Huntsville, Alabama, United States
Tuscon, Arizona, United States
Anaheim, California, United States
Azusa, California, United States
Carmichael, California, United States
Chula Vista, California, United States
Cypress, California, United States
Fresno, California, United States
Garden Grove, California, United States
Harrisburg, California, United States
Irvine, California, United States
Lancaster, California, United States
Mission Hills, California, United States
Oakland, California, United States
Orange, California, United States
Pasadena, California, United States
San Diego, California, United States
San Luis Obispo, California, United States
Boulder, Colorado, United States
Colorado Springs, Colorado, United States
Wheat Ridge, Colorado, United States
Boynton Beach, Florida, United States
Jupiter, Florida, United States
Miami, Florida, United States
New Smyma Beach, Florida, United States
Ocala, Florida, United States
St. Petersburg, Florida, United States
Zephyrhills, Florida, United States
Atlanta, Georgia, United States
Honolulu, Hawaii, United States
Boise, Idaho, United States
Moline, Illinois, United States
Oak Forrest, Illinois, United States
Rockford, Illinois, United States
Clive, Iowa, United States
Lexington, Kentucky, United States
Baton Rouge, Louisiana, United States
Metairie, Louisiana, United States
Chevy Chase, Maryland, United States
Hollywood, Maryland, United States
Lutherville, Maryland, United States
Prince Federick, Maryland, United States
Chaska, Minnesota, United States
Jackson, Mississippi, United States
Jefferson City, Missouri, United States
Washington, Missouri, United States
Egg Harbor, New Jersey, United States
Albuquerque, New Mexico, United States
Binghamton, New York, United States
Rochester, New York, United States
Greensboro, North Carolina, United States
High Point, North Carolina, United States
Raleigh, North Carolina, United States
Bismarck, North Dakota, United States
Dayton, Ohio, United States
Mogadore, Ohio, United States
Oklahoma City, Oklahoma, United States
Medford, Oregon, United States
Portland, Oregon, United States
Duncansville, Pennsylvania, United States
Lansdale, Pennsylvania, United States
Anderson, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Bristol, Tennessee, United States
Chattanooga, Tennessee, United States
Germantown, Tennessee, United States
Jackson, Tennessee, United States
Kingsport, Tennessee, United States
Nashville, Tennessee, United States
Amarillo, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Ogden, Utah, United States
Charlottesville, Virginia, United States
Chesapeake, Virginia, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Milwaukee, Wisconsin, United States
Monroe, Wisconsin, United States
Kippa-Ring, , Australia
St. John's, Newfoundland and Labrador, Canada
Newmarket, Ontario, Canada
Richmond Hill, Ontario, Canada
Toronto, Ontario, Canada
Longueuil, Quebec, Canada
Regina, Saskatchewan, Canada
Hradec Králové, , Czechia
Tallinn, , Estonia
Riga, , Latvia
Valmiera, , Latvia
Kaunas, , Lithuania
Panevezys, , Lithuania
Vilnius, , Lithuania
Bratislava, , Slovakia
Nitra, , Slovakia
Prešov, , Slovakia
Sučany, , Slovakia
Countries
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References
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Metz DC, Howden CW, Perez MC, Larsen L, O'Neil J, Atkinson SN. Clinical trial: dexlansoprazole MR, a proton pump inhibitor with dual delayed-release technology, effectively controls symptoms and prevents relapse in patients with healed erosive oesophagitis. Aliment Pharmacol Ther. 2009 Apr 1;29(7):742-54. doi: 10.1111/j.1365-2036.2009.03954.x. Epub 2009 Feb 7.
Peura DA, Metz DC, Dabholkar AH, Paris MM, Yu P, Atkinson SN. Safety profile of dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed release formulation: global clinical trial experience. Aliment Pharmacol Ther. 2009 Nov 15;30(10):1010-21. doi: 10.1111/j.1365-2036.2009.04137.x. Epub 2009 Sep 4.
Wyrwich KW, Mody R, Larsen LM, Lee M, Harnam N, Revicki DA. Validation of the PAGI-SYM and PAGI-QOL among healing and maintenance of erosive esophagitis clinical trial participants. Qual Life Res. 2010 May;19(4):551-64. doi: 10.1007/s11136-010-9620-x. Epub 2010 Feb 27.
Friedlander EA, Pallentino J, Miller SK, VanBeuge SS. The evolution of proton pump inhibitors for the treatment of gastroesophageal reflux disease. J Am Acad Nurse Pract. 2010 Dec;22(12):674-83. doi: 10.1111/j.1745-7599.2010.00578.x. Epub 2010 Nov 24.
Related Links
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For the Dexilant package insert refer to this link
Other Identifiers
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2006-000419-90
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1113-9433
Identifier Type: REGISTRY
Identifier Source: secondary_id
T-EE05-135
Identifier Type: -
Identifier Source: org_study_id
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